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Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
CK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7. 1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.
Study details:
This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study of CK-301 (cosibelimab), a fully human monoclonal IgG1 antibody targeting PD-L1. The study will consist of 3 periods: Screening (up to 28 days), Treatment (28-day cycles), and Follow-up (up to 6 months of visits with survival follow-up for select cohorts). Following the dose escalation portion of the study, additional evaluable subjects may be included in order to further characterize safety and efficacy at selected doses and/or in specific patient sub-groups.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2017-09-20
Primary completion: 2021-11-18
Study completion finish: 2024-12-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT03212404
Intervention or treatment
DRUG: CK-301 (cosibelimab)
Conditions
- • Carcinoma, Non-Small-Cell Lung
- • Head and Neck Cancer
- • Melanoma
- • Merkel Cell Carcinoma
- • Renal Cell Carcinoma
- • Urothelial Carcinoma
- • Classical Hodgkin Lymphoma
- • Cutaneous Squamous Cell Carcinoma
- • Endometrial Cancer
- • Lung Neoplasms
- • Carcinoma, Small Cell
- • Malignant Mesothelioma, Advanced
- • Non Hodgkin Lymphoma
Find a site
Closest Location:
Research Site
Research sites nearby
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Research Site
South Brisbane, Queensland, Australia
Research Site
Woolloongabba, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: CK-301 (cosibelimab)
| DRUG: CK-301 (cosibelimab)
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Dose Limiting Toxicity | Not Specified | Up to 4 weeks |
Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 (or most current version) | Not Specified | Screening through 4 weeks after study completion, an average of 6 months |
Confirmed Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) | Not Specified | Part 2 Only: Average of 6 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Confirmed Best Overall Response (BOR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) | Not Specified | Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months |
Duration of Response (DoR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) | Not Specified | Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months |
Objective response rate and duration of response (DOR) based on Modified RECIST 1.1 for immune based therapeutics | Not Specified | Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months |
Overall Survival (OS) | Not Specified | Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months |
Pharmacokinetic parameter: AUC (0-t) of CK-301 | Not Specified | Baseline up to 12 weeks after study completion, an average of 6 months |
Pharmacokinetic parameter: AUC (0-infinity) of CK-301 | Not Specified | Baseline up to 12 weeks after study completion, an average of 6 months |
Pharmacokinetic parameter: Cmax of CK-301 | Not Specified | Baseline up to 12 weeks after study completion, an average of 6 months |
Pharmacokinetic parameter: Tmax of CK-301 | Not Specified | Baseline up to 12 weeks after study completion, an average of 6 months |
Pharmacokinetic parameter: T(1/2) of CK-301 | Not Specified | Baseline up to 12 weeks after study completion, an average of 6 months |
Number of subjects with anti-CK-301 antibodies | Not Specified | Baseline up to 12 weeks after study completion, an average of 6 months |
Frequently Asked Questions
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